Trials / Recruiting
RecruitingNCT03137095
Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI
Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants - Optional Sub-Study: Research Brain MRI
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cognitive testing | computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 \& 5. |
| OTHER | Research Brain MRI | Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6. |
Timeline
- Start date
- 2017-02-20
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
- First posted
- 2017-05-02
- Last updated
- 2025-03-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03137095. Inclusion in this directory is not an endorsement.